Multi-connected biological reaction bag

Abstract

The utility model discloses a multi-connected biological reaction bag which comprises at least two bag bodies, the bag bodies are connected through a connecting part, and the width of the connecting part is 5-10mm. The multi-union biological reaction bag adopts a multi-union design, can be used for process development and production in the fields of mRNA in-vitro transcription, enzymatic reaction, chemical synthesis and the like, and improves the process development flux and the production efficiency compared with a single biological reaction bag in the current market.

Description

Technical Field

[0001] This utility model belongs to the field of bioreactor bag technology, specifically relating to multi-unit bioreactor bags. Background Technology

[0002] In the fields of biopharmaceuticals, biotechnology, and chemicals, disposable consumables are finding increasingly widespread applications due to their ease of use. In the biopharmaceutical field, mRNA vaccines offer several advantages, including short development cycles and the ability to induce both humoral and cellular immunity, earning them the title of third-generation vaccine technology. mRNA vaccine stock solutions are typically prepared through in vitro transcription. The reaction containers for in vitro transcription are often reaction vessels or disposable bioreactor bags. Recently, disposable bioreactor bags have gained increasing popularity due to their ease of use and ability to prevent cross-contamination.

[0003] Currently, most commercially available disposable bioreactor bags are modified from cell culture bags, consisting of a bag body and multiple inlets / outlets, and are modular. However, such reaction bags can only perform one reaction at a time. When it is necessary to prepare mRNA stock solutions for multiple antigens, or to study various reaction parameters for mRNA stock solution preparation, using the current modular disposable bioreactor bags requires completing one batch of reactions before starting the next batch, thus lengthening the process development and production time.

[0004] Therefore, in order to address the above-mentioned technical problems, it is necessary to provide a multi-unit bioreactor bag.

[0005] The information disclosed in this background section is intended only to enhance the understanding of the overall background of this utility model and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Utility Model Content

[0006] The purpose of this invention is to provide a multi-unit bioreactor bag, which solves the problem that current single-unit bioreactor bags can only carry out one reaction. The multi-unit bioreactor bag of this invention can be used for process development and production, and can improve process development throughput and production efficiency.

[0007] To achieve the above objectives, the technical solution provided by a specific embodiment of this utility model is as follows:

[0008] A multi-unit bioreactor bag includes at least two bag bodies connected to each other by a connecting part with a width of 5-10 mm.

[0009] In one or more embodiments of this utility model, the connecting portion between two adjacent bag bodies is provided with a plurality of through holes along its length direction.

[0010] In one or more embodiments of this utility model, the through holes at both ends of the connecting portion along its length are rectangular holes, and the through hole between two rectangular holes is a circular hole; or,

[0011] The through holes located at both ends of the connecting part along its length are oblong holes, and the through hole between the two oblong holes is a circular hole.

[0012] In one or more embodiments of this utility model, the bag body is rectangular, square, rhomboid, circular, semi-circular, arc-shaped, or trapezoidal.

[0013] In one or more embodiments of this utility model, the bag body is rectangular in shape, with a length of 5 to 30 cm and a width of 3 to 20 cm.

[0014] In one or more embodiments of this utility model, all the bags are arranged in a straight line, or all the bags are arranged in a matrix.

[0015] In one or more embodiments of this utility model, the bag body comprises, from the inside out, a layer of ultra-low density polyethylene, an adhesive layer, an ethylene-vinyl alcohol copolymer layer, an adhesive layer, and a linear low density polyethylene layer stacked together.

[0016] In one or more embodiments of this utility model, the bag body is provided with at least one inlet and at least one sampling port.

[0017] In one or more embodiments of this utility model, the injection port is provided with an injection mechanism, the injection mechanism includes a silicone tube connected to the bag body and a needleless injector connected to the silicone tube, and the end of the needleless injector is provided with a nut;

[0018] The sampling port is equipped with a sampling mechanism, which includes a silicone tube connected to the bag body and a needleless sampler connected to the silicone tube. The end of the needleless sampler is equipped with a nut.

[0019] In one or more embodiments of this utility model, the bag body is provided with an inflation port, the inflation port is connected to an inflation tube, and the inflation tube is connected to an air filter.

[0020] Compared with the prior art, the multi-unit bioreactor bag in this utility model adopts a multi-unit configuration, combining multiple bags to carry out multiple reactions simultaneously. It can be used for various purposes such as formulation research of reaction systems, exploration of process conditions, and process scale-up, thereby improving the throughput of process development.

[0021] Multi-unit bioreactor bags can be used for production applications in fields such as in vitro mRNA transcription, enzymatic biosynthesis, and chemical reactions. Multiple reactions can be carried out on a specific scale, improving production efficiency.

[0022] Multi-unit bioreactor bags are more convenient to operate than single-unit bioreactor bags. For example, a multi-unit bioreactor bag, consisting of 9 individual bags, is a single-unit design, making it more convenient to use and reducing errors caused by environmental factors.

[0023] Multi-unit bioreactor bags are for single use, reducing the risk of cross-contamination compared to reusable stainless steel or glass reactors. If a small number of reactions are required, the bag can be cut off with scissors for individual use, or the connecting part can be manually torn open using the perforation, effectively avoiding waste and conserving resources. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the structure of the multi-unit bioreactor bag in Embodiment 1 of this utility model;

[0026] Figure 2 This is a schematic diagram of the sampling mechanism and the injection mechanism in Embodiment 1 of this utility model;

[0027] Figure 3 This is a schematic diagram of the bag body in Embodiment 1 of this utility model;

[0028] Figure 4 This is a schematic diagram of the structure of the multi-unit bioreactor bag in Embodiment 2 of this utility model;

[0029] Figure 5 This is a schematic diagram of the air filter structure in Embodiment 2 of this utility model;

[0030] Figure 6 This is a schematic diagram of the structure of the multi-unit bioreactor bag in Embodiment 3 of this utility model.

[0031] Explanation of key figure labels:

[0032] 1. Bag body; 11. Inlet; 12. Sampling port; 13. Ultra-low density polyethylene layer; 14. Adhesive layer; 15. Ethylene-vinyl alcohol copolymer layer; 16. Linear low density polyethylene layer; 17. Inflation port; 171. Inflation tube; 172. Air filter; 2. Connecting part; 21. Rectangular hole; 22. Circular hole; 31. Silicone tube; 32. Needle-free sampler; 33. Needle-free injector; 34. Nut. Detailed Implementation

[0033] To enable those skilled in the art to better understand the technical solutions of this utility model, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of this utility model.

[0034] Example 1

[0035] like Figure 1 As shown, in one embodiment of this utility model, the multi-unit bioreactor bag includes nine bags 1 arranged in a matrix: three bags 1 arranged horizontally and three bags 1 arranged vertically. The number of bags 1 can be adjusted according to actual needs, such as two, three, four, five, or six bags 1. Each bag 1 is rectangular in shape, with a length of 13cm, a width of 7.5cm, and a thickness of 0.32mm. This size is sufficient to meet the material requirements for a single reaction. Specifically, in other embodiments, the length of the bag 1 can be set to 5cm, 10cm, 20cm, or 30cm, and the width of the bag 1 can be set to 3cm, 10cm, 15cm, or 20cm.

[0036] Adjacent bags 1 are connected by a connecting part 2, which is 8mm wide. In other embodiments, the width of the connecting part 2 can also be set to 5mm or 10mm. The multi-unit reaction bag provided in this embodiment can carry out multiple reactions simultaneously. In practical use, in order to improve the flexibility of the multi-unit reaction bag, such as when carrying out one or a few reactions, the connecting part 2 can be cut with scissors to separate a single bag 1 or a few bags 1 for reaction.

[0037] Combination Figure 2The bag body 1 has a sample inlet 11, which is connected to a sample injection mechanism. The sample injection mechanism specifically includes a silicone tube 31 connected to the sample inlet 11, and a needleless syringe 33 connected to the silicone tube 31. The end of the needleless syringe 33 is equipped with a nut 34 to seal it. In use, the nut 34 is unscrewed, and the reaction material is introduced into the bag body 1 through the sample inlet 11. Air is then introduced into the bag body 1 through the sample inlet 11 to inflate it. The nut 34 is then screwed on to maintain a sealed state. During inflation, a 0.22μm filter can be connected at the inlet to reduce the risk of contamination.

[0038] The bag body 1 is also provided with a sampling port 12, which is located on the same side of the bag body 1 as the inlet port 11. In other embodiments, the sampling port 12 and the inlet port 11 may also be located on different sides of the bag body 1, and multiple sampling ports may be provided. The sampling port 12 is connected to a sampling mechanism, which specifically includes a silicone tube 31 connected to the sampling port 12 of the bag body 1. The silicone tube 31 is connected to a needleless sampler 32, and the end of the needleless sampler 32 is provided with a nut 34 to seal the needleless sampler 32. During the reaction process, in order to monitor the reaction process, process sampling is performed through the needleless sampler 32. When sampling, the nut 34 is unscrewed, and an appropriate amount of sample is drawn with a syringe for testing. After the reaction is completed, the sample can also be harvested through the needleless sampler 32.

[0039] Combination Figure 3 The multi-unit bioreactor bag in this embodiment is mainly used in the fields of biopharmaceuticals and biotechnology. To meet the needs of the field, the bag body 1 includes, from the inside out, a stacked ultra-low density polyethylene layer 13, an adhesive layer 14, an ethylene-vinyl alcohol copolymer layer 15, an adhesive layer 14, and a linear low density polyethylene layer 16. The ultra-low density polyethylene layer 13 is in direct contact with the reactants inside the bag body 1, and has excellent chemical compatibility and biosafety, with minimal impact on the reaction. The ethylene-vinyl alcohol copolymer layer 15 can effectively block oxygen, carbon dioxide, and water vapor, further reducing the impact of the external environment on the reaction inside the bag body 1. The linear low density polyethylene layer 16 can improve the mechanical strength of the bag body 1, and also gives the bag body 1 bioinertness against fluid contact materials. The adhesive layer 14 mainly plays an adhesive role, and its main material is acrylic resin.

[0040] Example 2

[0041] like Figure 4 and Figure 5As shown, the difference between this embodiment and embodiment 1 is that, in order to improve the convenience of sample injection and sampling, the bag body 1 is provided with 3 injection ports 11 and 3 sampling ports 12. Of course, in other embodiments, the number of injection ports 11 can be set to 2, 4, 5 or other numbers, and the number of sampling ports 12 can also be set to 2, 4, 5 or other numbers, depending on actual needs.

[0042] In addition, air can be injected into the bag 1 through the injection port 11 as shown in Example 1, with a filter connected during injection to reduce contamination. However, in actual reactions, multiple injections into the bag 1 are required. If the method in Example 1 is used, where air is injected through the injection port 11 each time and the filter is installed back and forth, there will still be a certain probability of contamination. Therefore, in this embodiment, an inflation port 17 is provided on the bag 1, and an inflation pipe 171 is provided at the inflation port 17. An air filter 172 is installed on the inflation pipe 171. Injecting air into the bag 1 through the inflation port 17 not only allows for repeated inflation, but also eliminates the need for repeated installation of the air filter 172, greatly reducing the possibility of contamination of the environment inside the bag 1.

[0043] Example 3

[0044] like Figure 6 As shown, the difference between this embodiment and Embodiment 1 is that, to improve the ease of separating the bag 1, a through hole is provided along the length direction of the connecting portion 2 between every two adjacent bag 1s, so that the user can manually tear open the connecting portion 2. Furthermore, the through holes at both ends of the connecting portion 2 between adjacent bag 1s are rectangular holes 21, and the through hole between two rectangular holes 21 is a circular hole 22. The rectangular holes 21 allow the user to insert their fingers to facilitate tearing open the connecting portion 2, while the circular hole 22 ensures that the two bag 1s remain effectively connected when separation is not required, increasing the difficulty of separating the bag 1s to a certain extent and reducing the possibility of the bag 1s separating due to misoperation during normal use. In other embodiments, the rectangular hole 21 can also be set as an oblong hole.

[0045] In summary, this invention combines multiple bags 1 via connecting parts 2, enabling simultaneous processing of multiple reactions. Alternatively, the connecting parts 2 can be cut or manually torn to separate individual or a few bags 1 for further reaction, avoiding waste and conserving resources. Furthermore, the multi-unit bioreactor bag of this invention can be used with a wave-type bioreactor or a constant-temperature shaker. During use, air is introduced into the bags 1 to maintain their three-dimensional shape, and shaking facilitates uniform mixing of the reaction solution.

[0046] It will be apparent to those skilled in the art that this invention is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or essential characteristics of this invention. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within this invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0047] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A multi-unit bioreactor bag, comprising a bag body, characterized in that, The bag body consists of at least two parts, which are connected by a connecting part with a width of 5-10 mm. The connecting portion between two adjacent bag bodies has several through holes along its length. The through holes at both ends of the connecting part along its length are rectangular holes, and the through hole between two rectangular holes is a circular hole; or, The through holes located at both ends of the connecting part along its length are oblong holes, and the through hole between the two oblong holes is a circular hole.

2. The multi-unit bioreactor bag according to claim 1, characterized in that, The bag shape can be rectangular, square, rhomboid, circular, semi-circular, arc-shaped, or trapezoidal.

3. The multi-unit bioreactor bag according to claim 1, characterized in that, The bag is rectangular in shape, with a length of 5-30cm and a width of 3-20cm.

4. The multi-unit bioreactor bag according to claim 1, characterized in that, All the bags are arranged in a straight line, or all the bags are arranged in a matrix.

5. The multi-unit bioreactor bag according to claim 1, characterized in that, The bag body comprises, from the inside out, a layer of ultra-low density polyethylene, an adhesive layer, an ethylene-vinyl alcohol copolymer layer, an adhesive layer, and a linear low density polyethylene layer, stacked in sequence.

6. The multi-unit bioreactor bag according to claim 1, characterized in that, The bag is provided with at least one inlet and at least one sampling port.

7. The multi-unit bioreactor bag according to claim 6, characterized in that, The inlet is equipped with an injection mechanism, which includes a silicone tube connected to the bag body and a needleless injector connected to the silicone tube. The end of the needleless injector is equipped with a nut. The sampling port is equipped with a sampling mechanism, which includes a silicone tube connected to the bag body and a needleless sampler connected to the silicone tube. The end of the needleless sampler is equipped with a nut.

8. The multi-unit bioreactor bag according to claim 1, characterized in that, The bag is equipped with an inflation port, which is connected to an inflation tube, and the inflation tube is connected to an air filter.

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